← FDA Drug Approvals (Drugs@FDA)
PALIPERIDONE PALMITATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE INC · Approved 2025-05-16
Drug application
- FDA Application #
ANDA216674- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PALIPERIDONE PALMITATE
- Generic name
- Paliperidone Palmitate
- Active ingredients
- PALIPERIDONE PALMITATE
- Dosage form
- INJECTABLE
- Route
- SUSPENSION, EXTENDED RELEASE
- Marketing status
- None (Tentative Approval)
- Sponsor
- ACCORD HLTHCARE INC
- First approval
- 2025-05-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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